at AbbVie in North Chicago, Illinois, United States
Job Description
Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
This position supports the case processing organization to achieve its mission of improving patient lives globally through consistent and accurate delivery of high quality, relevant, and timely adverse event management by providing effective oversight of external providers of Pharmacovigilance services for AbbVie.
Responsibilities:
+ Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event information (clinical and post marketing) is performed in a compliant and timely manner to comply with global regulations including:
+ Seriousness assessment
+ Labeling
+ Causality
+ Initial and Follow – up
+ Conducting oversight of vendors to ensure company standards for quality, compliance and productivity are met. Remaining current on knowledge and skills required for case processing.
+ Supporting vendor case quality, case processing metrics and agility using the Abbvie core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One AbbVie; Decide Smart and Sure.
+ Supporting and participating in audits and inspections as needed.
+ Supporting development of materials and delivering training in conjunction with the vendor, including train-the-trainer, special-topics, refresher, and internal AbbVie trainings as needed.
+ Other duties may be assigned based on the need or work requirement of the organization.
Qualifications
Minimum Qualifications:
+ Bachelor’s degree in Life Science. RN, BSN, BS, BS Pharm preferred.
+ Candidates lacking the appropriate degree but with previous pharmaceutical experience may be considered.
+ 2-4 years clinical experience or 2-3 years clinical experience and 1-year Pharmacovigilance experience.
+ Demonstrates ability to lead project work. Proven success in results-driven process management.
+ Demonstrates ability to work collaboratively in team environment.
+ Core knowledge of Industry regulations (ICH, FDA, EMEA, MHRA).
+ Competent in case processing processes, procedures, and conventions.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.?
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.?
+ This job is eligible to participate in our short-term incentive programs. ?
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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ?
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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html